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New treatment option for Hypertrophic Obstructive Cardiomyopathy
Official title Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
ClinicalTrials.gov ID: NCT05332691
What this study is testing
- What it's testing
- The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, single-center, first-in-man study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
- Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the...
You likely can't join if
- Patients who were pregnant.
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
- Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
- Patients whose estimated life expectancy \< 12 m.
- Patient who were non-compliant.
- Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.